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当前本网站药物产品种数共 8524 处方药 8148 非处方药 269 保健品/医疗用具 107

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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗微生物药物->抗真菌药物
处方药:处方药
包装规格: 50克/支
计价单位:
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生产厂家中文参考译名:
STIEFEL LABS INC
生产厂家英文名:
STIEFEL LABS INC
该药品相关信息网址1:
http://www.vusionointment.com/
该药品相关信息网址2:
http://www.vusion.com/
该药品相关信息网址3:
http://www.rxlist.com/vusion-drug.htm
原产地英文商品名:
VUSION OINTMENT 50g/piece
原产地英文药品名:
MICONAZOLE NITRATE/ZINC OXIDE
中文参考商品译名:
VUSION药膏 50克/支
中文参考药品译名:
硝酸咪康唑/氧化锌
原产地国家批准上市年份:
2006/02/16
英文适应病症1:
Treatment of diaper dermatitis caused by Candida
临床试验期:
完成
中文适应病症参考翻译1:
治疗由念珠菌引起的尿布皮炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(201062723560711.pdf)的“原文Priscribing Information”为准
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部分中文Vusion Ointment处方资料(仅供参考)

    Vusion药膏(含0.25%的硝酸咪康唑,15%的氧化锌和81.35%的白凡士林)。

    该药用于四周大以上的患儿,治疗由念珠菌引起的尿布皮炎(DDCC)。Vusion在美国是唯一通过批准治疗该病的处方药。

    在美国2岁以下的儿童大约有800万,每年有100万门诊患者有尿布皮炎,其中40%以上是DDCC。到目前为止,一般治疗DDCC的方法有使用抗真菌药物、类固醇药物以及其他不是用于DDCC或婴儿使用的药物。
 
    Vusion不含类固醇,其活性成分为硝酸咪康唑,抗真菌效果显著。临床试验结果显示,DDCC患儿使用该药进行为期三天的治疗之后,获得的疗效达到了统计显著性水平。

Vusion Ointment
Generic Name: miconazole nitrate, zinc oxide and white petrolatum ointment
Date of Approval: February 16, 2006

Treatment for: Diaper Dermatitis Complicated by Candidiasis
The U.S. Food and Drug Administration (FDA) has approved Vusion (0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum) Ointment for the treatment of diaper dermatitis complicated by candidiasis (DDCC) in infants 4 weeks and older.

This inflammatory condition occurs when diaper dermatitis, also known as diaper rash, is complicated with a fungal infection caused by yeast known as Candida. The existence of Candida is readily determined by microscopic evaluation for presence of pseudohyphae or budding yeast. Vusion is the only prescription product approved for the treatment of this condition in the United States.

There are approximately 8 million infants under the age of two in the U.S. It is estimated that diaper dermatitis is observed in approximately one million pediatric outpatient visits each year. Additionally, it is estimated that of all diaper dermatitis cases treated by physicians, more than 40% are complicated by the yeast Candida. Until now, common treatment options have included the use of antifungal products, steroids, and combination products not specifically approved for the treatment of DDCC or for use on infants.

Vusion is a steroid-free formulation that contains the active ingredient miconazole nitrate at a concentration of 0.25%, which directly treats the infection with proven antifungal efficacy. The ointment base for Vusion is comprised of zinc oxide and white petrolatum, which are the main components in most common diaper rash products. In clinical trials, statistically significant improvement was observed in infants with DDCC within three days of treatment with Vusion.

In the pivotal Phase 3 clinical study, more than twice the percentage of patients treated with Vusion achieved the primary endpoint of elimination of the yeast and complete clearing of all signs and symptoms of the disease at day 14, one week after stopping treatment, as compared with patients treated with the vehicle (zinc oxide and petrolatum). At the end of treatment (day 7), the average reduction in the signs and symptoms score, as determined by the Diaper Dermatitis Severity Score, was 72% with Vusion versus 25% with the vehicle ointment. The double-blind, vehicle-controlled study, which was conducted at 20 sites in the United States and Latin America, included 236 children under the age of three years who were diagnosed with DDCC.

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 详细处方信息以本药内容附件PDF文件(201062723560711.pdf)的“原文Priscribing Information”为准
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更新日期: 2015-08-26
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